510(k) · Cleared
Recalled · 2008Maxim Accel (Vanguard) PS+ Bearings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 21, 2004 as substantially equivalent to K023546 (Biomet, Inc., 2003) after a 29-day review. Its family tree reaches back 2 generations to 1992. 249 later devices descend from it. It has been recalled once.
- Decided
- May 21, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915132 (1992). 3 ancestors in all. 249 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK915132 MCK Maximum Congruent Knee) Knee SystemBiomet, Inc. · 1992 · Recalled
- 1 generation backK023546 Maxim Accel Knee SystemBiomet, Inc. · 2003 · Recalled
- This deviceK041046 Maxim Accel (Vanguard) PS+ BearingsBiomet, Inc. · 2004
- Descendant · cites it directly · 248 of its ownK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- Descendant · 2 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 114 of its ownK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- Descendant · 3 generations on · 88 of its ownK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
Showing 5 of 249 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 249 · See all- K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008 · cites it directly248descendants
- K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 2 generations on119descendants
- K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010 · 2 generations on114descendants
- K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012 · 3 generations on88descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915132 | MCK Maximum Congruent Knee) Knee System | Biomet, Inc. | 1992 | 6 |
| −1 | K023546 | Maxim Accel Knee System | Biomet, Inc. | 2003 | 13 |
| 0 (this device) | K041046 | Maxim Accel (Vanguard) PS+ Bearings | Biomet, Inc. | 2004 | — |
| +1 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| +2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| +2 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| +3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| +3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 10 | 0 |
| 2016 | 14 | 0 |
| 2017 | 8 | 0 |
| 2018 | 12 | 0 |
| 2019 | 17 | 0 |
| 2020 | 19 | 0 |
| 2021 | 23 | 0 |
| 2022 | 20 | 0 |
| 2023 | 19 | 0 |
| 2024 | 21 | 0 |
| 2025 | 24 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023546 | Maxim Accel Knee SystemSummary page 1…g (insert) Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560) Substantially Equivalent Devices: Maxim® Accel Knee System - K023546 Device Description: The Maxim® Accel (VanguardTM) PS+ Bearing is intended to replace the articular portions of the knee joint. T… | 2003 |
What descends from it? (249)
See all 2493 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2008 | Not classified | Z-0289-2009 | Process control | The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K080528 (Biomet Orthopedics, Inc., 2008) has gone furthest, with 248 descendants of its own.
- 14 other devices also cite its predicate K023546.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is a single use implant intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041046: Maxim Accel (Vanguard) PS+ Bearings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041046
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026